Status:
RECRUITING
Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Central Nervous System Disease
Multiple Sclerosis
Eligibility:
All Genders
1-99 years
Brief Summary
Inflammatory or degenerative diseases of the brain and spinal cord, such as multiple sclerosis, may be related to problems with an individual s immune system. However, more information is needed on th...
Detailed Description
OBJECTIVE The goal of this study is to define the pathophysiological mechanisms underlying the development of disability in immune-mediated disorders of the central nervous system (CNS) and to distin...
Eligibility Criteria
Inclusion
- PATIENT INCLUSION CRITERIA (for in-person and telemedicine sub-cohorts):
- Presentation with a clinical syndrome consistent with immune-mediated CNS disorder and/or
- Neuroimaging evidence of inflammatory and/or demyelinating/dysmyelinating CNS disease
- At least 12 years old at the time of enrollment
- Willing to share medical records (including past MRI results) with the study team.
- Adults: Able to give informed consent on their own or via a Legally Authorized Representative (LAR) or Durable Power of Attorney (DPA); or Minors: parent or legal guardian able to give consent, with child willing to give assent, if reasonable based on their age and assent capacity
- For in-person sub-cohort: Able to undergo the required procedures, including LP, MRI and clinical/functional evaluations
- PATIENT EXCLUSION CRITERIA (for in-person and telemedicine sub-cohorts):
- Significant medical condition that would make participation in research part of evaluation impossible or risky
- For in-person sub-cohort: Medical contraindications for MRI (i.e. any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed)
- Unwilling to consent for collection of biological samples or their cryopreservation
- PATIENT INCLUSION CRITERIA for processing of collected biological samples:
- Presentation with a clinical syndrome consistent with immune-mediated CNS disorder and/or
- Neuroimaging evidence of inflammatory and/or demyelinating/ dysmyelinating CNS disease
- Ability to obtain either direct or surrogate informed consent for sample processing and storage
- Aged 0+ years
- HEALTHY VOLUNTEER (in person) INCLUSION CRITERIA:
- At least 18 years old at the time of enrollment
- Vital signs are found within normal range at the time of the screening visit
- Able to give informed consent
- Able and willing to undergo related research procedures, such as blood draw, LP
- HEALTHY VOLUNTEER (in person) EXCLUSION CRITERIA:
- Systemic inflammatory disorder, or inflammatory or non-inflammatory neurological diseases
- Previous or current history of alcohol and substance abuse
- Medical contraindications for MRI (i.e. any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed)
- Medical contraindication for LP
- Psychological contraindications for MRI (i.e. claustrophobia). This will be assessed at the time the medical history is collected
- Pregnancy or current breastfeeding
- Any contraindications to having study procedures done
- History of auditory disorder (i.e. hearing impairment, known impaired acoustic reflex, tinnitus)
- HEALTHY VOLUNTEER SUB-STUDY TO OBTAIN NORMATIVE DATA FOR THE SMARTPHONE APPS:
- Because this sub-study collects no personal identifiable information (PII), there are no inclusion/exclusion criteria. Participating subjects are self-declared as not having any neurological deficit, which would be the same population that would provide normative data if the apps were freely available via App store.
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT00794352
Start Date
October 1 2008
Last Update
January 8 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892